Clinical Trial Protocol Deviation Incident Form
Study Title
Protocol Number
Site Name
Site Number
Subject ID
Visit Date
Date of Deviation
Type of Deviation
Major
Minor
Other
Description of Protocol Deviation
Reason for Deviation
Immediate Actions Taken
Corrective/Preventive Actions
Reporter Name
Role/Position
Date of Reporting
Principal Investigator Review/Comments
Principal Investigator Name
PI Signature
Date of PI Review